Gastric CancerPhase 1/2NCT02689284
Combination Margetuximab and Pembrolizumab for Advanced, Metastatic HER2(+) Gastric or Gastroesophageal Junction Cancer
A Phase 1/2 study testing Margetuximab 10 mg/kg, Margetuximab 15 mg and Pembrolizumab in people with Gastric Cancer and Stomach Cancer, run by MacroGenics at 28 sites in 5 countries.
Trial summary
This main purpose of this clinical study is to learn about the safety and activity of margetuximab and pembrolizumab combination treatment in patients with HER2+ gastric and gastroesophageal junction cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Stomach Cancer, Esophageal Cancer
- What is being tested?
- Margetuximab 10 mg/kg, Margetuximab 15 mg and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 28 sitesin 5 countries
- Study dates
- Jan 2016to Jan 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- Age ≥ 18 years old (or minimum age based upon local regulations)
- Unresectable locally advanced or metastatic histologically proven HER2+ gastroesophageal junction (GEJ) or gastric cancer. Gastric Cancer Expansion Phase will include only gastric cancer patients with 3+ HER2 positivity.
- HER2+ as 3+ (as defined in AJCC staging manual 8th edition) by IHC or in-situ hybridation (ISH) amplified.
- Have received prior treatment with trastuzumab.
- Have received treatment with at least one or more lines of cytotoxic chemotherapy in the metastatic setting.
Show all 10Show fewer
- Resolution of chemotherapy, immunotherapy or radiation-related toxicities.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
- Measurable disease as per RECIST 1.1 criteria.
Who cannot join
- Patients with symptomatic central nervous system (CNS) metastases.
- Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment.
- History of prior allogeneic bone marrow, stem-cell or solid organ transplantation.
- Treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 3 weeks prior to the initiation of study drug.
- Treatment with radiation therapy within 3 weeks prior to the initiation of study drug administration.
- Treatment with corticosteroids (≥10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days prior to the initiation of study drug administration.
Show all 11Show fewer
- History of clinically-significant cardiovascular disease.
- Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation.
- History of (non-infectious) pneumonitis that required steroids or presence of active pneumonitis
- Clinically-significant gastrointestinal disorders, such as perforation, gastrointestinal bleeding, or diverticulitis.
- Evidence of active viral, bacterial, or systemic fungal infection.
Trial locations and contacts
28 sites in 5 countries.
28 sites in 5 countries
United States11 sites
Johns Hopkins University Medical Center
Baltimore, Maryland, 21231
Dana-Farber Cancer Institute/Harvard University Medical Center
Boston, Massachusetts, 02215
University of Chicago
Chicago, Illinois, 60637
Karmanos Cancer Institute
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27710
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale School of Medicine
New Haven, Connecticut, 06520
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19107
Swedish Cancer Institute
Seattle, Washington, 98104
Washington University School of Medicine
St Louis, Missouri, 63110
Georgetown University-Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
South Korea9 sites
Kyungbuk National University Hospital
Daegu, 41404
Gachon University Gil Medical Center
Incheon, 21565
Chonbuk National University Hospital
Seoul, 54907
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Bundang Hospital
Seoul
Seoul National University Hospital
Seoul
Singapore3 sites
National Cancer Centre
Singapore
National University Hospital
Singapore
Raffles Hospital
Singapore
Taiwan3 sites
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Tri-Service General Hospital
Taipei
Canada2 sites
Juravinski Cancer Centre - McMaster University
Hamilton, Ontario, L8V5C2
McGill University Health Centre
Montreal, Quebec, H4A3J1
About this study
Official title: A Phase 1b/2, Open Label, Dose Escalation Study of Margetuximab in Combination With Pembrolizumab in Patients With Relapsed/Refractory Advanced HER2+ Gastroesophageal Junction or Gastric Cancer
This main purpose of this clinical study is to learn about the safety and activity of margetuximab and pembrolizumab combination treatment in patients with HER2+ gastric and gastroesophageal junction cancer.
Read the detailed description
Detailed Description: Both margetuximab and pembrolizumab are monoclonal antibodies used in combination to treat HER2+ gastric and gastroesophageal junction cancer. This study has two parts: Dose Escalation and Dose Expansion. The Dose Escalation phase of the study will evaluate safety of escalating doses of the combination treatment. The Dose Expansion phase will evaluate safety and activity of the combination in patients with gastric or gastroesophageal cancer once the final dose and schedule are defined. In addition, a cohort of patients with HER2+ 3+ gastric cancer patients will be enrolled in the Dose Expansion Phase.
- Conditions
- Gastric Cancer, Stomach Cancer, Esophageal Cancer
- Being tested
- Margetuximab 10 mg/kg, Margetuximab 15 mg, Pembrolizumab
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Margetuximab 10 mg/kgBiological
Also called MGAH22
Margetuximab treatment is administered intravenously (IV) once every 21-day cycle
Margetuximab 15 mgBiological
Also called MGAH22
Margetuximab treatment is administered IV once every 21-day cycle
PembrolizumabBiological
Also called MK-3475
Pembrolizumab treatment is administered IV once every 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Margetuximab 10 mg/kg plus pembrolizumab 200 mg | Experimental | margetuximab administered in combination with pembrolizumab Receives: Biological: Margetuximab 10 mg/kg; Biological: Pembrolizumab |
| Cohort 2: Margetuximab 15 mg/kg plus pembrolizumab 200 mg | Experimental | margetuximab administered in combination with pembrolizumab Receives: Biological: Margetuximab 15 mg; Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Dose Limiting Toxicities
Characterize maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of margetuximab when administered in combination with pembrolizumab
Measured: 21 days
Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs).
The number of patients that experience either an AE or a SAE during the study participation
Measured: up to 24 months
Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment
Investigate the preliminary anti-tumor activity as measured by response to treatment of margetuximab when administered in combination with pembrolizumab, using conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: 12 months
Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment Using irRC Criteria
Investigate the preliminary anti-tumor activity, as measured by objective response rate (ORR) of margetuximab when administered in combination with pembrolizumab, using immune-related response criteria (irRC).
Measured: 12 Months
Duration of Response
Duration of response is calculated at the time from CR or PR to relapse or cancer progression.
Measured: up to 24 months
Secondary outcomes (10)
Overall Survival (OS)
The median length of time between first dose of study medication and death from any cause.
Measured: 24 Months
Progression Free Survival (PFS)
The interval between the first dose of study medication and progression of disease or death from any cause.
Measured: 24 Months
Change From Baseline in Pharmacodynamic Markers in Whole Blood
The planned assessment included examination of markers of T-cell activation
Measured: from first dose to the end of treatment, average about 12 months
Analysis of HER2 Tumor Cell Membrane Expression in Biopsy Specimens Before and After Treatment
Measured: from first dose to the end of treatment, average 12 months.
Number of Patients Who Develop Treatment-emergent Anti-drug Antibodies to Margetuximab (Immunogenicity)
Measured: Assessed Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Day 1 of every odd cycle, and end of treatment visit, average 12 months
Maximum Concentration of Margetuximab at Steady State
Measurement of PK characteristics is limited to margetuximab. No analysis of pembrolizumab was conducted.
Measured: At end of infusion on Cycle 1, Day 1. Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months
Area Under the Concentration Time Curve at Steady State (AUC ss)
AUC is a mathematical calculation that describes the variation in drug concentration in the blood over time.
Measured: Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months
Clearance
Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time.
Measured: Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months.
Volume of Distribution at Steady State
The volume of distribution is related to a whether how much drug is distributed to body tissues, or remains in the bloodstream.
Measured: Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit average 12 months .
Terminal Half-life
Terminal half-life is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium.
Measured: Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit average 12 months .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2021
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- MacroGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689284
- Sponsor's protocol ID
- CP-MGAH22-05
- Status last verified
- Feb 2025
- First submitted
- 27 Jan 2016
- Last updated
- 17 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Catenacci DV, Kang YK, Uronis HE, Lee KW, Ng MC, Enzinger PC, Park SH, Gold PJ, Lacy J, Hochster HS, Oh SC, Kim YH, Marrone KA, Kelly RJ, Juergens RA, Kim JG, Alcindor T, Sym SJ, Song EK, Chee CE, Chao Y, Kim S, Oh DY, Yen J, Odegaard JI, Lagow E, Li D, Sun J, Kaminker P, Moore PA, Rosales MK, Park H. Circulating Tumor DNA as a Predictive Biomarker for Clinical Outcomes With Margetuximab and Pembrolizumab in Pretreated HER2-Positive Gastric/ Gastroesophageal Adenocarcinoma. Oncology (Williston Park). 2023 Apr 25;37(4):176-183. doi: 10.46883/2023.25920992.
PubMed 37104758Catenacci DVT, Kang YK, Park H, Uronis HE, Lee KW, Ng MCH, Enzinger PC, Park SH, Gold PJ, Lacy J, Hochster HS, Oh SC, Kim YH, Marrone KA, Kelly RJ, Juergens RA, Kim JG, Bendell JC, Alcindor T, Sym SJ, Song EK, Chee CE, Chao Y, Kim S, Lockhart AC, Knutson KL, Yen J, Franovic A, Nordstrom JL, Li D, Wigginton J, Davidson-Moncada JK, Rosales MK, Bang YJ; CP-MGAH22-5 Study Group. Margetuximab plus pembrolizumab in patients with previously treated, HER2-positive gastro-oesophageal adenocarcinoma (CP-MGAH22-05): a single-arm, phase 1b-2 trial. Lancet Oncol. 2020 Aug;21(8):1066-1076. doi: 10.1016/S1470-2045(20)30326-0. Epub 2020 Jul 9.
PubMed 32653053
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Open Label, Dose Escalation Study of Margetuximab in Combination With Pembrolizumab in Patients With Relapsed/Refractory Advanced HER2+ Gastroesophageal Junction or Gastric Cancer
- ClinicalTrials.gov ID
- NCT02689284
- Acronym / sponsor ID
- CP-MGAH22-05
- Conditions
- Gastric Cancer, Stomach Cancer, Esophageal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- MacroGenicsIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Posted 4 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This main purpose of this clinical study is to learn about the safety and activity of margetuximab and pembrolizumab combination treatment in patients with HER2+ gastric and gastroesophageal junction cancer.
Detailed description
Detailed Description: Both margetuximab and pembrolizumab are monoclonal antibodies used in combination to treat HER2+ gastric and gastroesophageal junction cancer. This study has two parts: Dose Escalation and Dose Expansion. The Dose Escalation phase of the study will evaluate safety of escalating doses of the combination treatment. The Dose Expansion phase will evaluate safety and activity of the combination in patients with gastric or gastroesophageal cancer once the final dose and schedule are defined. In addition, a cohort of patients with HER2+ 3+ gastric cancer patients will be enrolled in the Dose Expansion Phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Margetuximab 10 mg/kg plus pembrolizumab 200 mg | Experimental | Biological: Margetuximab 10 mg/kg, Biological: Pembrolizumabmargetuximab administered in combination with pembrolizumab |
| Cohort 2: Margetuximab 15 mg/kg plus pembrolizumab 200 mg | Experimental | Biological: Margetuximab 15 mg, Biological: Pembrolizumabmargetuximab administered in combination with pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed written informed consent.
- Age ≥ 18 years old (or minimum age based upon local regulations)
- Unresectable locally advanced or metastatic histologically proven HER2+ gastroesophageal junction (GEJ) or gastric cancer. Gastric Cancer Expansion Phase will include only gastric cancer patients with 3+ HER2 positivity.
- HER2+ as 3+ (as defined in AJCC staging manual 8th edition) by IHC or in-situ hybridation (ISH) amplified.
- Have received prior treatment with trastuzumab.
Key exclusion criteria (11 listed)
- Patients with symptomatic central nervous system (CNS) metastases.
- Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment.
- History of prior allogeneic bone marrow, stem-cell or solid organ transplantation.
- Treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 3 weeks prior to the initiation of study drug.
- Treatment with radiation therapy within 3 weeks prior to the initiation of study drug administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Margetuximab 10 mg/kgAlso: MGAH22Margetuximab treatment is administered intravenously (IV) once every 21-day cycle | Biological | Cohort 1: Margetuximab 10 mg/kg plus pembrolizumab 200 mg |
| Margetuximab 15 mgAlso: MGAH22Margetuximab treatment is administered IV once every 21-day cycle | Biological | Cohort 2: Margetuximab 15 mg/kg plus pembrolizumab 200 mg |
| PembrolizumabAlso: MK-3475Pembrolizumab treatment is administered IV once every 21-day cycle | Biological | Cohort 1: Margetuximab 10 mg/kg plus pembrolizumab 200 mg, Cohort 2: Margetuximab 15 mg/kg plus pembrolizumab 200 mg |
Primary outcome
Number of Patients With Dose Limiting Toxicities
Time frame: 21 days
Characterize maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of margetuximab when administered in combination with pembrolizumab
Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs).
Time frame: up to 24 months
The number of patients that experience either an AE or a SAE during the study participation
Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment
Time frame: 12 months
Investigate the preliminary anti-tumor activity as measured by response to treatment of margetuximab when administered in combination with pembrolizumab, using conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment Using irRC Criteria
Time frame: 12 Months
Investigate the preliminary anti-tumor activity, as measured by objective response rate (ORR) of margetuximab when administered in combination with pembrolizumab, using immune-related response criteria (irRC).
Duration of Response
Time frame: up to 24 months
Duration of response is calculated at the time from CR or PR to relapse or cancer progression.
10 secondary outcomes
Overall Survival (OS)
Time frame: 24 Months
Progression Free Survival (PFS)
Time frame: 24 Months
Change From Baseline in Pharmacodynamic Markers in Whole Blood
Time frame: from first dose to the end of treatment, average about 12 months
Analysis of HER2 Tumor Cell Membrane Expression in Biopsy Specimens Before and After Treatment
Time frame: from first dose to the end of treatment, average 12 months.
Number of Patients Who Develop Treatment-emergent Anti-drug Antibodies to Margetuximab (Immunogenicity)
Time frame: Assessed Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Day 1 of every odd cycle, and end of treatment visit, average 12 months
Maximum Concentration of Margetuximab at Steady State
Time frame: At end of infusion on Cycle 1, Day 1. Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months
Area Under the Concentration Time Curve at Steady State (AUC ss)
Time frame: Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months
Clearance
Time frame: Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months.
Volume of Distribution at Steady State
Time frame: Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit average 12 months .
Terminal Half-life
Time frame: Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit average 12 months .
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37104758Catenacci DV, Kang YK, Uronis HE, Lee KW, Ng MC, Enzinger PC, Park SH, Gold PJ, Lacy J, Hochster HS, Oh SC, Kim YH, Marrone KA, Kelly RJ, Juergens RA, Kim JG, Alcindor T, Sym SJ, Song EK, Chee CE, Chao Y, Kim S, Oh DY, Yen J, Odegaard JI, Lagow E, Li D, Sun J, Kaminker P, Moore PA, Rosales MK, Park H. Circulating Tumor DNA as a Predictive Biomarker for Clinical Outcomes With Margetuximab and Pembrolizumab in Pretreated HER2-Positive Gastric/ Gastroesophageal Adenocarcinoma. Oncology (Williston Park). 2023 Apr 25;37(4):176-183. doi: 10.46883/2023.25920992.
- Derived from this study: PubMed 32653053Catenacci DVT, Kang YK, Park H, Uronis HE, Lee KW, Ng MCH, Enzinger PC, Park SH, Gold PJ, Lacy J, Hochster HS, Oh SC, Kim YH, Marrone KA, Kelly RJ, Juergens RA, Kim JG, Bendell JC, Alcindor T, Sym SJ, Song EK, Chee CE, Chao Y, Kim S, Lockhart AC, Knutson KL, Yen J, Franovic A, Nordstrom JL, Li D, Wigginton J, Davidson-Moncada JK, Rosales MK, Bang YJ; CP-MGAH22-5 Study Group. Margetuximab plus pembrolizumab in patients with previously treated, HER2-positive gastro-oesophageal adenocarcinoma (CP-MGAH22-05): a single-arm, phase 1b-2 trial. Lancet Oncol. 2020 Aug;21(8):1066-1076. doi: 10.1016/S1470-2045(20)30326-0. Epub 2020 Jul 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Margetuximab 10 mg/kg, Margetuximab 15 mg and Pembrolizumab in people with Gastric Cancer and Stomach Cancer, run by MacroGenics at 28 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, South Korea, Singapore, Taiwan, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Dose Limiting Toxicities (time frame: 21 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02689284, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.